Class I Recall

DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625

Summary

The FDA issued a Class I for DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Te by Bard Access Systems, Inc.. Reason: this is a downstream recall of class I recall RES 98777.

Details

Source

Device Recall

External ID

Z-2985-2026

Action Date

2026-09-23

Status

Ongoing

Product Description

DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625300; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626120; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626150; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626200; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626240; Niagara Dual-Lumen Short-Term Curved Extension Dialysis Catheter, REF: 5766200

Lot/Code Info: REF/UDI-DI/Lot(Expiration): 5625150/801741042096/ REKS1082(8/31/2026), REKS2493(10/31/2026), REKU1654(10/31/2026), REKV2899(1/31/2027), REKX0416(3/31/2027), REKY1371(4/30/2027), REKZ0520(5/31/2027); 5625200/801741042102/ REKQ3365(8/31/2026), REKR0913(9/30/2026), REKR3442(9/30/2026), REKS3566(10/31/2026), REKT3039(11/30/2026), REKV0934(12/31/2026), REKW2112(1/31/2027), REKX1756(3/31/2027), REKY1379(4/30/2027), REKZ2330(5/31/2027), RELP1350(7/31/2027); 5625240/801741042119/ REKS1561(9/30/2026), REKU1624(12/31/2026), REKW1234(2/28/2027), REKY0255(4/30/2027), REKY2419(4/30/2027), RELP2149(7/31/2027); 5625300/801741042126/ REKQ1106(8/31/2026), REKS1554(10/31/2026), REKW1239(2/28/2027), REKY1363(4/30/2027), RELN2943(6/30/2027); 5626120/801741042133/ REKU1592(12/31/2026), REKW0662(2/28/2027), REKY2397(4/30/2027); 5626150/801741042140/ REKQ3359(8/31/2026), REKS3561(10/31/2026), REKW0658(2/28/2027), REKY1388(4/30/2027), RELP1359(7/31/2027); 5626200/801741042157/ REKW1244(2/28/2027), REKY0237(4/30/2027); 5626240/801741042164/ REKR2191(9/30/2026), REKU1680(12/31/2026), REKW1230(1/31/2027), REKY0250(4/30/2027); 5575150/ 5766200/801741045714/ REKT1903(11/30/2026)

Quantity Affected: 22,980

Reason for Recall

this is a downstream recall of class I recall RES 98777

Distribution

US: FL, IL, OH, VA, MD, TX, WI, GA, TN, IN, SC, NC, MI, PA, OR, OK, AZ, MS, NJ, AL, CA, CO, MA, NV, ID, MO, LA, WA, KY, IA, NH, NY, KS, HI, NE, MN, MT, WY, AR, RI, WV, UT, PR, DE, CT, ME, DC, ND, NM, SD

Type: Voluntary: Firm initiated

Recall Initiated: 2026-08-10

Company

Bard Access Systems, Inc.

Salt Lake City, UT

Context & Analysis

This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.

This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.

Bard Access Systems, Inc. has 24 FDA actions in our database, including 19 recalls and 5 clearances.

Frequently Asked Questions

What is a Class I recall?

A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Bard Access Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Bard Access Systems, Inc. have FDA actions?

Bard Access Systems, Inc. has 24 FDA actions in our database, including 19 recalls and 5 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-2985-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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